US 3366103 A
Description (OCR text may contain errors)
Jan. 30, 1968 G. H. KELLER 3,366,103
' O BLOOD COLLECTING ASSEMBLY Filed June 24, 1965 United States Patent O 3,366,103 BLOGD COLLECTING ASSEMBLY George H. Keller, Ridgewood, NJ., assignor to Becton,
Dickinson and Company, East Rutherford, NJ., a corporation of New Jersey Fiiedf .lune 24, 1965, Ser. No. 466,583 7 Claims. (Cl. 12S- 2) ABSTRACT OF THE DISCLOSURE An improved blood collecting assembly including a cylindrical, air-evacuated container provided at one end with a resealable penetrable stopper and a holder having a double ended cannula. The holder has circumferentially spaced ribs extending inwardly, each rib having an intermediate portion of increased height which engages with the periphery of the stopper thereby holding the container to the holder while permitting the container to be longitudinally shifted therein by applying a deliberate force thereto, thereby causing one end of the cannula to penetrate the stopper when the force is applied.
The present invention relates to a structurally and functionally improved blood collecting assembly and, more particularly, to an assembly of this type having a novel and superior holder construction.
In the medical, biological and laboratory fields, assemblies employing evacuated tubes and containers are frequently used in the collection of blood. Assemblies of this type are disclosed in U.S. Patent No. 2,460,641 granted Feb. 1, 1949, U.S. Patent No. 3,136,440 granted June 9, 1964, and U.S. Patent No. 3,141,460 granted July 2l, 1964. The evacuated containers are suitably sealed by a stopper made of elastomeric material and not only adapted to provide the desired seal but permit the insertion and removal of the inner end of a double ended cannula. This cannula is attached to the forward end of the container holder which, at the same time, serves to slidably retain the stopper end of the container therein. In this connection, a number of different approaches have been suggested for retaining the container in the holder in the desired position relative to the inner end of the cannula both prior to actual use of the assembly or during its manipulation during the blood collecting cycle prior to the complete penetration of the stopper by the inner cannula end.
It is a principal object of this invention to provide a blood collecting assembly in which an improved holder is employed; and in this regard, the holder is adapted to retain the container therein to thereby provide a ready-touse unit while keeping the frictional resistance between inner surfaces of the holder and the stopper at a .minimum thereby permitting relatively easy insertion of the sealed container into the holder during assembly and also at the selected period following the initial penetration of the stopper by the inner cannula end while minimizing danger of disassociation of the stopper from container upon retraction of the evacuated container relative to the holder.
Another object is to provide a disposable holder and united needle thereby affording extreme convenience in field use by having a unit ready to use without concern for assembly and even disassembly during use; this design not only permitting the packaging of an evacuated tube and holder-needle unit assembled into a ready-to-use unit but also permits the holder-needle unit to be placed in individual packages with evacuated containers packaged in selected groups in larger evacuated cans.
In accordance with the present invention, a typical evacuated container, closed at one end and open at the other end, is employed for the blood collecting technique.
3,366,193 Patented Jan. 30, 1968 The open end of the container is sealed by a penetrable stopper which is adapted to maintain the internal vacuum and then reseal itself upon penetration and withdrawal of a cannula following the blood collecting process. This container is adapted to be conveniently held in a holderneedle unit. The holder is essentially cylindrical in configuration having a rear open end into which the penetrable stopper end of the container is adapted to be inserted. The other end of the holder is reduced or restricted and formed with a reduced bore. A double ended cannula is disposed in this bore with its inner penetrating end projecting inwardly of the bore of the holder. A bonding material is interposed between the cannula and the restricted holder end whereupon this material is adapted to adhere with the material of the cannula and the material of the holder. This bonding material may embrace the typical epoxy bonding systems and, as such, may not possess the optimum bonding affinity desired with the resin materials employed in the fabrication of the holder. In such cases, the bond is supplemented by a mechanical interlock which is provided by the penetration of the bonding material into recesses formed in the bore of the holder restricted end. The internal diameter of the holder is larger than the external diameter of the container as well as the stopper. The desired holding or gripping action between the holder and the container is obtained by a series of circumferentially spaced and radially inwardly extending ribs of a suiiicient height to engage with the periphery of the stopper. In this manner, the desired holding pressure is obtained between the holder and the container while, at the same time, permitting sliding movement therebetween and maintaining the frictional forces at a minimum. Intermediate portions of a selected number of these ribs are enlarged to increase the holding or gripping pressure on the stopper at such location. This location is at a position in which the penetrable stopper is in close proximity with the inner penetrating end of the cannula. In this manner, an indication is provided for the locating as well as the presence of the stopper at this position. The ribs, forwardly of this location as was the case rearwardly thereof, are reduced but, nevertheless, provide sufficient gripping pressures on the stopper while permitting the escape of air around the stopper during penetration thereof by the cannula. In the packaging of the holder-needle unit either separately from the container or assembled therewith, the outer penetrating end of the cannula will be protected by a shield adapted to engage with the outer surfaces of the restricted holder end.
Other objects and advantages will become apparent from the following detailed description which is to be taken in conjunction with the accompanying drawings y illustrating a somewhat preferred embodiment of the invention and in which:
FIG. 1 is a longitudinal sectional view of the assembled blood collecting assembly with the cannula shield shown in phantom and with a proposed sealed package also shown in phantom for maintaining the interior thereof and the assembly in sterile condition;
FIG. 2 is another longitudinal sectional view of the holder-needle unit with a proposed sealed package shown in phantom for maintaining the interior thereof and the enclosed unit in sterile condition;
FIG. 3 is an enlarged, fragmentary sectional View showing the relationship of the stopper and retaining ribs when the parts are assembled as shown in FIG. 1;
FIG. 4 is an enlarged fragmentary section taken along j the line 4-4 of FIG. 3; and
In the drawings, a blood collecting assembly is shown and is adapted to be supplied commercially in a pre-packaged sterile condition ready for use to be ultimately discarded following the blood collecting operation. The assembly includes an evacuated container 12 having a rear closed end 14 yand a forward open end 16 closed and sealed by a penetrable stopper 18. The container 12 and the stopper 18 is disclosed and described in detail in U. S. Patent No. 3,136,440. Suflice it to say that the container 12 is evacuated and substantially light transparent t-o facilitate the observation of the interior particularly during the yblood collecting operation. The stopper 18, on the other hand, is of such proportion and formed from an elastomeric material which assures its retention in the open end of the container 12 during substantially all stages of use. As will be observed, the outer end of the stopper 1'8 includes a circumferentially extending enlarged periphery which, together with the end 16 of the container 12, is inserted into and suitably retained by a holder-needle unit 22 which comprises a holder 22 and double ended needle 24.
Referring now to the holder-needle un-it, it should beunderstood initially that this unit may .be supplied commercially separately from the evacuated container 12 to be eventually assembled in the field. In this manner, the holder-needle unit will be separately packaged under sterile conditions with the forward penetrating end 26 of the cannula 24 protected by the shield 28 adapted to be frictionally mounted on the restricted forward end 30 of the holder 22.
The double ended needle 24 is conveniently secured to the restricted forward end 30 of the holder 22 with its inner penetrating end 32 disposed inwardly of the bore of the cylindrical holder 22. In this regard, the intermediate portion of the cannula 24 is disposed in the bore 34. A bonding material 36 is interposed between the cannula 24 and the bore defining surfaces of the restricted end 30. The bonding material may be of the type disclosed in U.S. Patent No. 3,186,408 granted June l, 1965, as well as the disclosures mentioned therein. A contemplated bonding material will, accordingly, embrace an epoxy bonding system. Such systems have acceptable bonding ainity with the usual metals employed for cannulas 24 but, in a number of instances, have less than the required amount of bonding aflinity for the resin material employed for the holder 22. In such cases, the bonding action is supplemented by means of a mechanical interlock which is provided by one or more recesses 38 forming part of the bore 34 of the restricted end 30 of the holder 22.
Referring now to the holder 22, it will be appreciated that a substantially elongated cylindrical configuration is present with the rear open end 40 having a radially outwardly extending and interrupted liange 42 which is adapted to be engaged by the forenger and index lfinger of the hand of the operator during the manipulation and handling of the assembly 10. The materi-al employed for the holder 22 may be selected from a wide variety of materials including polypropylene or one of the materials disclosed in U.S. Patent N-o. 3,186,408 or the disclosures mentioned therein. Suice it to say that the holder material should be suliiciently light transparent to permit observation of the flow of liquid or blood from the inner penetrating end 32 into the container 12.
The internal bore 44 of the holder 22 is proportione-d and constructed to facilitate the entry therein of the container 12 and stopper 1-8 and, at the same time, assure against undesirable or unintentional removal thereof. Under the circumstances, the internal diameter of the bore 44 is greater than the external diameter of the container 12 as well as the periphery 20 of the stopper 18. These components are conveniently and adequately held and gripped relative to the holder 22 by a series or network of -ribs extending between the stopper 18 and the holder 22. These ribs may assume any one of a number of seleeted patterns and, as disclosed in the exemplary embodiment, may be of substantially elongated form and in a circumferentially spaced pattern. These ribs 46 are integral with the internal surfaces of the holder 22 and extend radially inwardly for a sufficient distance to engage and grip the circumferentially extending periphery 20 of the stopper 18. The pressure created by this engagement is suiiicient to hold the container 12 and stopper 18 within the bore 44 of the holder 22. At the same time, this engagement is not sufliciently great to create frictional forces that will serve to hinder or deter the desired and efficient insertion of the container 12 and stopper 18 into the holder 22 particularly during the actual blood collecting operation. It will be appreciated that, with this arrangement, air is permitted to escape or ow around the circumferentially extending periphery 20 during the `shifting of the stopper 18 within the holder 22.
A circumferentially extending rib 48 is provided on the face of the bore 44 to serve as an indicator of a fixed or certain relative disposition of the stopper 18 and inner end '32 of the cannula 24. In other words, when the front face of the stopper 18 is aligned with this rib 48, the inner penetrating end 32 of the cannula 24 is either proximal the stopper or embedded therein in a manner shown in FIG. 1. When the front face of the stopper 18 is forced across this rib 48 during the blood collecting operation, the lumen of the cannula 24 will then be in communication with the vacuum present in the container 12.
As explained in the above, the container 12 and stopper 18 may be assembled with the holder 22 to provide -a pre-packaged unit and offered or merchandised in a single packaged unit. In some instances, the evacuated container may be packaged separately but once assembled with the holder 22 will be either held or stored in this condition for prolonged periods of time. It will then be desirable, if not necessary, to assure the retention Of the evacuated container within the holder 22. This assurance is provided by an enlarged portion 50 of a selected number of the ribs 46. Thus, these enlarged ribbed portions S0 served to increase the frictional force and grip of the ribs 46 on the circumferentially extending periphery 20 of the stopper 18. In addition, an abutting lbeveled shoulder is thereby provided against which the 'rear face of the periphery 20 is adapted to engage when the front face of this periphery is aligned with the rib 48. This relationship is clearly shown in the enlarged fragmentary representation of FIG. 3.
While the present assembly 10 may be used in diverse applications, as explained it is primarily intended to be employed in the collection of blood. If not preassembled in the same package, an evacuated container will be mounted in a holder 22 with the front face of the stopper 18 aligned with the indicating rib 48. During this insertion, the periphery 22 of the stopper 18 will yieldingly bear to a slight extent against the ribs 46 and, to a greater extent, as the enlarged ribbed portions 50 are traversed. During this insertion, the ribs 46 in cooperation with the periphery 20 will assure the proper alignment of the evacuated container relative to the holder and cannula 24. The embedding of the full point of the inner end 32 of the cannula avoids blood leakage on entry into a vein and will also prevent premature loss of vacuum. With the shield 28 removed, the operator will now grasp the holder 22 and introduce the outer penetrating end 26 of the ycannula 24 into the vein of a donor. Immediately thereafter, the puncture of the stopper 18 -by the inner end 32 of the cannula is completed to thereby communicate the lumen of the cannula with the interior of the container. Blood will ow immedaitely upon insertion of the outer end 26 of the cannula in the selected vein. Therefore, aside from venus pressure, the vacuum within the container 12 will assist in the aspirating of blood through the lumen of the cannula to thereby fill the container interior to the desired extent. Thereupon, the
container 12 together with stopper 18 may be retracted to the position at which the front face of he stopper 18 is aligned with the rib 48 or else may be entirely Withdrawn from the holder 22 and the outer end 26 of the cannula withdrawn from the vein of the donor.
Thus, among others, the several aforenoted objects and advantages are most effectively attained. Although a single somewhat preferred embodiment of this invention has been disclosed and described in detail herein, it should be understood that this invention is in no sense limited thereby and its scope is to be determined by that of the appended claims.
1. A liquid collecting assembly comprising a substantially elongated -cylindrical air evacuating container having a closed end and an open end, a penetrable stopper extending across the container open end to seal the interior thereof, a substantially elongated cylindrical container holder having an open end and restricted end disposed about the container open end and the stopper thereat in substantial coaxial relationship therewith, the internal diameter of said holder being relatively greater than the exterior diameter of said container whereby the holder is spaced radially outwardly relative to the container, the container closed end extending beyond the holder open end, the holder restricted end having a coaxial bore, a double ended cannula disposed in said bore and having an outer penetrating end and an inner penetrating end disposed Within said holder bore, connecting means for connecting the cannula to the holder restricted end, holding means for holding the stopper and consequently the container within the holder bore and at selected positions therein while permitting the container to be longitudinally shifted therein by applying a deliberate force to the closed end of the container and While maintaining the frictional resistance between the stopper and the holder at a minimum, said holding means comprising integral, circumferentially spaced ribs extending radially inwardly into engagement with the outer periphery of the stopper, wherein certain opposed ribs each include an intermediate portion of increased height to increase the holding pressure on the stopper to thereby assure its retention in the holder, said intermediate portion being at the position at which the inner penetrating end of the cannula is in a predetermined position relative to the stopper, said stopper being at said intermediate portion when said container and the holder are assembled prior to collecting liquid.
2. The invention in accordance with claim 1 wherein the maximum outer diameter of the stopper is less than the internal diameter of the holder to permit rearward escape of air around the stopper during shifting of the container toward the holder restricted end.
3. The invention in accordance with claim 1 wherein the connecting means include a bonding material interposed between the cannula and restricted end and being adhered thereto, the bore of said restricted end including recessed portions in which said bonding material is partially disposed to thereby provide a mechanical interlock supplementing the action of the bonding material.
4. A holder for a liquid collecting assembly comprising a substantially elongated cylindrical container holder having an open end and restricted end and adapted to receive an air evacuated elongated container having a penetrable stopper sealing one `of its ends, the internal diameter of the container and stopper whereby the container and stopper are adapted to be spaced radially inwardly relative to the holder, the holder restricted end having a coaxial bore adapted to receive a double ended cannula having an outer penetrating end and an inner penetrating end for disposition internally of the holder bore, holding means adapted to hold the stopper and consequently the container within the container bore and at selected positions therein while permitting the container to be longitudinally shifted therein by applying a deliberate force to the container and while maintaining the frictional resistance lbetween the stopper and holder at a minimum, said holding means comprising integral, circumferentially spaced ribs extending radially inwardly and adapted to enga-ge with the outer periphery of the stopper, wherein certain opposed ribs each include an intermediate portion of increased height to increase the holding pressure on the stopper to assure its retention in the holder, said intermediate portion being at a position at which the inner penetrating end of the cannula is at a predetermined position relative to the stopper.
5. The invention in accordance with claim 4 wherein connecting means are provided for connecting the cannula in the restricted end of the holder, the connecting means includes a bonding material interposed between the cannula and restricted end and being adhered thereto, the bore of said restricted end including recessed portions in which said bonding material is partially disposed to thereby provide a mechanical interlock supplementing the action of the bonding material.
6. The invention in accordance with claim 5 wherein a shield is mounted on the holder restricted end and protectively about the outer penetrating end of the cannula.
7. The invention in accordance with claim 4 wherein a sealed package surrounds the holder, the holder together with the interior of the package being substantially sterile, and means for permitting the removal of the package to permit use of the holder.
References Cited UNITED STATES PATENTS 1,881,415 10/1932 Tingleff 1218-276 2,607,344 8/1952 Brown 12S- 218.1 2,941,531 6/ 1960 Stevens 128m221 3,074,541 1/1963 Roehr 128-276 3,141,460 7/1964 Tsochatzopoulos 12S-276 3,291,128 12/1966 ONeil 128-218 DALTON L. TRULUCK, Primary Examiner.